NCT04793373

Brief Summary

The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
2mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
May 2022Jun 2026

First Submitted

Initial submission to the registry

March 9, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

March 9, 2021

Last Update Submit

July 19, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Success of epidural localization

    Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture

    30 minutes

Study Arms (2)

EpiFaith® group

EXPERIMENTAL

Study subject will have the epidural placement with an EpiFaith® syringe.

Device: Syringe

Conventional group

ACTIVE COMPARATOR

Study subject will have the epidural placement with a conventional glass syringe.

Device: Syringe

Interventions

SyringeDEVICE

A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Conventional groupEpiFaith® group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParturients who require labor epidural placement
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females 18 years of age and older at screening
  • Request labor epidural analgesia
  • Able to give informed consent to participate in the study
  • American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
  • BMI ≤ 40 kg/m2

You may not qualify if:

  • BMI \> 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
  • Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
  • Any allergy to bupivacaine or fentanyl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 11, 2021

Study Start

May 15, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

US(1)